Glioma
Conditions
Keywords
Glioma, intraoperative ultrasound, gross total resection, quality of life
Brief summary
The main goal of high grade glioma (HGG) surgery is to achieve gross total resection (GTR) without causing new neurological deficits1-8. Intraoperative navigated high resolution ultrasound (US) is a promising new tool to acquire real-time intraoperative images to localize and to resect gliomas9-12. The aim of this study was to investigate whether intraoperative guided surgery leads to a higher rate of GTR, when compared with standard non-ultrasound guided surgery.
Detailed description
Study design: The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure. Study population: Fifty patients with newly diagnosed contrast enhancing presumed high grade glioma on first MRI scan. Intervention: The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) . Main study parameters/endpoints: * Gross total resection (yes/no) * Extent of resection (%) * Neurological outcome (Karnofsky Performance Status) * Quality of Life (EORTC QLQ-C30 and QLQ-BN20 quality of life questionnaire) * Surgery associated neurological deficits (National Institutes of Health Stroke Scale) * Adverse events (classified according to the US National Cancer Institute common toxicity criteria version 4.0) * Survival time (days)
Interventions
PROCEDUREultrasound guided surgery.
during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection.
Sponsors
Stichting Coolsingel
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Gross total resection (yes/no) on post-operative T1 postcontrast MRI scans will be evaluated by a neuroradiologist who is blinded for the treatment arm.
Intervention model description
The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure. The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals of 18 years or older * Newly diagnosed, untreated, contrast enhancing presumed high-grade glioma * KPS ≥ 60 * Preoperative intention to perform gross-total resection of the enhancing tumor * Written informed consent conform ICH-GCP
Exclusion criteria
* Tumours crossing the midline basal ganglia, cerebellum, or brain stem prohibiting gross total resection * Multifocal contrast enhancing lesions * Pre-existing neurological deficit (e.g. aphasia, hemiparesis) due to neurological diseases (e.g. stroke) * Inability to give consent because of dysphasia or language barrier
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross total resection (Yes or No) | within 48 hours after surgery | Gross-total resection (yes vs. no): No residual contrast enhancement on post-operative MRI scans; 100% of all contrast enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological outcome (Karnofsky Performance status) | within 1 week after surgery | Karnofsky Performance status |
| Quality of Life (QLQ C30 questionnaires) | 1, 3 and 6 months after surgery | QLQ C30 questionnaires A brain tumor specific quality of life measurement tool |
| Extent of resection (%) | within 48 hours after surgery | as a continous variable The extent of resection (%) is a secondary outcome measurement defined as the residual tumor volumes on post-operative MRI studies compared to the operative tumor volume. |
| Surgery associated neurological deficits (National Institutes of Health Stroke Scale) | 1 month after surgery | National Institutes of Health Stroke Scale 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused typically by a stroke, however it is also used for tumor studies to assess functioning on the level of speech, motor and sensory functions. |
| Survival (time in days) | status will be checked 15 months after surgery | time measured from surgery until death in days. This study has a follow up of 6 months. However, when patients are alive at months after surgery, we will contact the general practictioner of the patient 15 months after the trial to obtain survival data. |
| Quality of Life (QLQ BN20 questionnaires) | 1, 3 and 6 months after surgery | QLQ BN20 questionnaires A brain tumor specific quality of life measurement tool |
Countries
Netherlands
Outcome results
None listed